Masy Systems, Inc.

Summary

Please join us for a dinner meeting on PDA's recently-released Technical Report 46, "Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User". This technical report deals with managing shipments of product in the "last mile" to the point of patient administration, and includes guidance on the proper handling of controlled-temperature medicinal products and devices along the final legs of the distribution chain. Our second topic for the evening will be a practical presentation on avoiding shipping logistical nightmares, which could include delays, customs hold-ups, temperature deviations, and even fines for non-compliance with shipping regulations. The dinner meeting will be preceded by an optional facility tour of Masy Systems, Inc., including their new BioPharma Storage Facility.

Speakers

Anthony (TJ) Rizzo
Strategic Account Engineer at Cold Chain Technologies

TOPIC: The Last Mile - PDA Technical Report TR-46

TJ's focus at Cold Chain Technologies is supporting key accounts with their thermal packaging, distribution, and logistics requirements. He has presented to the industry on several occasions regarding Cold Chain Logistics, was recently a key member of the PDA's Pharmaceutical Cold Chain Interest Group (PCCIG) "Last Mile" task force and is currently a workshop leader on the PCCIG "Risk Management for Temperature Controlled Distribution" task force. TJ has a strong understanding of industry requirements including USP 1079, PDA biotech sectors. TJ graduated from Pennsylvania State University with a bachelor's degree in Mechanical Engineering and is pursuing his MBA from the University of Massachusetts.

Jim DiTolla OPS
Manager at Biocair

TOPIC: Avoiding Logistics Nightmares

Mr. DiTolla graduated with a BA from Kansas University in 2002. He has been involved in the Specialty Logistics Industry for over five years and currently holds the position of Operations Manager for the Biocair facility in Boston, MA. He has built logistics solutions for a variety of unique projects involving both import and export of temperature sensitive and hazardous research materials ranging from single vials of New Chemical Entities (NCEs) to bulk shipments of API. As part of these projects, Mr. DiTolla has built up an in-depth understanding of the regulations and requirements that need to be complied with in order to ensure prompt and compliant handling of these specialty shipments.

Agenda

Tour of Masy Systems

3:30pm | 4:00pm | 4:30pm | Masy Systems will accomodate 3 tour times. Tour spots are limited, so register early for your time slot. Take a tour of their BioPharma Storage Facility, the Calibration Lab and Validation Services. Drinks and desserts available.

Masy Systems is located at 10-6 Lomar Park Drive, Pepperell, MA. (map and directions)

Registration and Social Hour at Alpine Grove

5:30pm - 6:30pm | Registration will begin at 5:30pm at Alpine Grove (6 minutes from Masy Systems). Drinks and appetizers will be available while socializing with vendors. (maps and directions)

Dinner and Presentations

6:30pm - 9:00pm | Dinner will begin at 6:30pm and presentations will begin at 7:00pm.

Sponsors

eschambers.com baxter.com biocair.com cagents.com

MesaLabs.com elpro.us Masy.com qpharmacorp.com

Sensitech.com Steris.com tobinscientific.com worldcourier.com